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Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

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Trial Profile

Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2025

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At a glance

  • Drugs Ketamine (Primary) ; Cycloserine/lurasidone
  • Indications Bipolar depression; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms SevereBD
  • Sponsors NeuroRX; NRx Pharmaceuticals

Most Recent Events

  • 17 Nov 2025 According to a NRx Pharmaceuticals media release, the NDA for NRX-100 for suicidal depression, initiated in Q4 2024 is expected to be completed in Q4 2025 with the addition of Real World Efficacy Data drawn from more than 60,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine to be submitted as part of the NDA. The Company applied to receive Commissioner's National Priority Voucher (CNPV), to reduce review time.
  • 17 Nov 2025 According to a NRx Pharmaceuticals media release, the company has refiled its Abbreviated New Drug Application (ANDA) following FDA notification of approval of a Suitability Petition for NRx's proposed strength for KETAFREE (preservative free ketamine), received supportive correspondence from FDA that no significant deficiencies were identified in the revised filing, and expects GDUFA date by Q2 2026.
  • 15 May 2025 According to a NRx Pharmaceuticals media release, NRX-100 (preservative-free IV ketamine) planned to complete New Drug Application (NDA) filing in Q2 2025, with expected 2025 PDUFA date; $4.3 million NDA submission fee waived by FDA. The Company also plans to file an Abbreviated New Drug Application (aNDA) for existing ketamine indications in Q2 2025

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